Donepezil Hydrochloride 1mg/1ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

1. What Donepezil Hydrochloride 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Donepezil Hydrochloride 1mg/1ml Oral Solution
3. How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6. Contents of the pack and other information

• if you are allergic to (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil Hydrochloride 1mg/1ml Oral Solution listed in section 6
• if you are breast feeding

Talk to your doctor or pharmacist before taking Donepezil Hydrochloride 1mg/1ml Oral Solution if you have ever had:

• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (such as irregular or very slow heart beat, heart failure, myocardial infraction)
• a heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family have ‘prolonged QT interval’
• low levels of magnesium or potassium in your blood
• asthma or other long term lung disease
• liver problems or hepatitis
• difficulty passing urine or mild kidney disease
• inherited intolerance of a sugar known as fructose

Also tell your doctor if you are pregnant or think you might be pregnant.

Donepezil Hydrochloride 1mg/1ml Oral Solution is not recommended for use in children and adolescents (younger than 18 years of age).

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine. This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take some time in the future if you continue to take Donepezil Hydrochloride 1mg/1ml Oral Solution. This is because these medicines may weaken or strengthen the effects of Donepezil Hydrochloride 1mg/1ml Oral Solution.

Especially tell your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems e.g. amiodarone, sotalol
• medicines for depression e.g. citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis e.g. pimozide, sertindole, ziprasidone
• medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• anti-fungal medicines e.g. ketoconazole
• other Alzheimer’s disease medicines, e.g. galantamine
• pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen or diclofenac sodium
• anticholinergics medicines e.g. tolterodine
• anticonvulsants e.g. phenytoin, carbemazepine
• medication for a heart condition e.g. quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants e.g. diazepam, succinylcholine
• general anaesthetic
• medicines obtained without a prescription e.g. herbal remedies.

If you are going to have an operation that requires you to have a general anaesthetic you should tell your doctor and the anaesthetist that you are taking Donepezil Hydrochloride 1mg/1ml Oral Solution. This is because Donepezil Hydrochloride 1mg/1ml Oral Solution may affect the amount of anaesthetic needed.

Donepezil Hydrochloride 1mg/1ml Oral Solution can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil Hydrochloride 1mg/1ml Oral Solution.

Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.

Food will not influence the effect of Donepezil Hydrochloride 1mg/1ml Oral Solution.

Donepezil Hydrochloride 1mg/1ml Oral Solution should not be taken with alcohol because alcohol may change its effect.

Donepezil Hydrochloride 1mg/1ml Oral Solution must not be used while breastfeeding.

If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Alzheimer’s disease may impair your ability to drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.

Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.

This medicine contains:

• sorbitol (E420). This medicine contains 250mg sorbitol in each 1ml dose. Sorbitol is a source of fructose. If your doctor has told you that you have intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine. A 5ml dose of Donepezil Hydrochloride 1mg/1ml Oral Solution supplies 1.25g of sorbitol and a 10ml dose of Donepezil Hydrochloride 1mg/1ml Oral Solution supplies 2.5g of sorbitol.
• propylene glycol (E1520). This medicine contains 62.2mg propylene glycol in each 1ml dose.
• benzoic acid (E210). This medicine contains 0.83mg benzoic acid in each 1ml dose.
• methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed).
• sodium metabisulphite (E223). Which may rarely cause hypersensitivity reactions and bronchospasm.
• this medicine contains less than 1mmol sodium (23mg) per 1ml dose, that is to say essentially “sodium-free”.

Usually, you will start by taking 5ml every night. After one month, your doctor may tell you to take 10ml every night. To take a 5ml dose pour the liquid into the dosing spoon to the line of 5ml. To take a 10ml dose pour the liquid into the dosing spoon to the line of 10ml. The amount of Donepezil Hydrochloride 1mg/1ml you will take may change depending on the length of time you have been taking this medicine and on what your doctor recommends.

The maximum recommended dose is 10ml each night. After taking your dose you should wash the dosing spoon with water and leave to air dry.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not alter the dose yourself without your doctor’s advice.

Donepezil Hydrochloride 1mg/1ml Oral Solution should be taken orally in the evening just prior to retiring. If you do experience abnormal dreams, nightmares, or difficulty in sleeping (see section 4) your doctor may advise you to take Donepezil Hydrochloride 1mg/1ml Oral Solution in the morning.

Your doctor or pharmacist will advise you on how long you should continue to take your medicine. You will need to see your doctor from time to time to review your treatment and assess your symptoms.

Do not stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution unless told to do so by your doctor. If you stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution the benefits of your treatment will gradually fade away.

DO NOT take more medicine than your doctor has told you to. Call your doctor immediately if you take more than you should. If you cannot contact your doctor, contact the local hospital Accident and Emergency department at once. Always take the bottle and the carton with you to the hospital so that the doctor knows what has been taken.

Symptoms of overdosing include feeling and being sick, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.

If you forget to take your medicine, just take your normal dose of medicine the following day at the usual time. Do not take a double dose to make up for a forgotten dose. If you forget to take your medicine for more than one week, call your doctor before taking any more.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of the medicines.

United Kingdom

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The active substance is donepezil hydrochloride.

• 5ml of Donepezil Hydrochloride 1mg/1ml Oral Solution contains 5mg of donepezil hydrochloride
• 10ml of Donepezil 1mg/1ml Oral Solution contains 10mg of donepezil hydrochloride
• Each 5ml dose contains 1.25g of sorbitol
• The other ingredients are sorbitol solution (E420), hydroxyethylcellulose, sodium benzoate (E211), methyl parahydroxybenzoate (E218), propylene glycol (E1520),sodium metabisulfite (E223), strawberry flavour (containing flavouring substances, propylene glycol (E1520), ethyl maltol, maltol), HCI sol 10% (for pH adjustment) and purified water.

Donepezil Hydrochloride 1mg/1ml Oral Solution is a clear colourless liquid with a strawberry odour.

Donepezil Hydrochloride 1mg/1ml Oral Solution is available in one strength of 1mg/1ml and is supplied in bottles of 150ml. The package also includes a 10ml dosing spoon.

or

(alternative manufacturer)

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

This medicinal product is authorised in the Member States of the EEA and United Kingdom (Northern Ireland) under the following names:

United Kingdom Donepezil Hydrochloride 1mg/1ml Oral Solution

Greece Rafazil 1mg/ml oral solution

Cyprus Rafazil 1mg/ml oral solution